effects of y-6 sublingual tablets for patients with acute ischemic stroke (future)

Conditions: Acute Ischemic Stroke; Large Vessel Occlusion; Reperfusion

Summary: this study aims to evaluate the efficacy of y-6 sublingual tablets in improving microcirculation dysfunction and reducing thrombo-inflammation in patients who had ais caused by lvo and received reperfusion therapy. moreover, we expect to evaluate the safety of using y-6 sublingual tablet in such study population.

this study rationale is based on the following scheme: in patients with acute ischemic stroke caused by lvo, receiving reperfusion therapy may cause futile recanalization and thus lead to microcirculation dysfunction and thrombo-inflammation as consequences. cilostazol has antiplatelet effects and bbb protection and dexborneol has anti-inflammatory effects; therefore, the multi-component tablet may exert neuroprotective effects in terms of improving microcirculation dysfunction and reducing thrombo-inflammation in patients with ais after reperfusion therapy. the primary purpose of this study is to investigate the proportion of modified-rankin scale (mrs) score recovered to 0\~1 score at 90±7 days after randomization. the follow-up duration is 3 months, and the visit schedule is as follows: subjects enrolled based on randomization procedures will receive visits at screening/baseline period, 24 ± 2 hours, 7 ± 2 days, 28 + 3 days and 90 ± 7 days after randomization, and in case of any events.

Eligibility criteria:
inclusion criteria: * 35 years old ≤ age ≤ 80 years old; * patients with acute ischemic stroke diagnosed within 24 hours of onset (time from onset to start of endovascular treatment); * patients with first stroke or mrs score 0-1 prior to this onset ; * patients with acute intracranial large vessel occlusion (lvo) confirmed by imaging examination, including occlusion of intracranial segments of internal carotid arteries, t-shaped bifurcation, mca m1 and/or m2 segments and aca a1 and/or a2 segments; * aspects score ≥ 6 when screening; * 6\<nihss score ≤ 25 after this onset; * patients who had the indications for mechanical thrombectomy and were scheduled for endovascular treatment; * patients or his/her legal representatives were able to understand and sign the informed consent. exclusion criteria: * severe disorder of consciousness: nihss 1a consciousness level ≥2 points; * patients with definite history of intracranial hemorrhage, including parenchymal hemorrhage, intraventricular hemorrhage, subarachnoid hemorrhage, subdural/external hematoma, etc. when screening; * patients with previously diagnosed intracranial tumor, arteriovenous malformation, or aneurysm when screening; * patients with bilateral lvo at anterior circulation or lvo at posterior circulation when screening; * patients with lvo of unknown or rare etiology, e.g., due to dissection, vasculitis, etc. when screening; * patients who have received treatment with tirofiban, warfarin, novel oral anticoagulants, argatroban, snake venom, defibrase, lumbrokinase or other defibrase therapy after onset, or platelet count \<100×10\^9/l; * patients with severe hepatic insufficiency or renal insufficiency and received dialysis for various reasons when screening (severe hepatic insufficiency was defined as alt \> 3 × uln or ast \>3 × uln; severe renal insufficiency was defined as serum creatinine \>3.0 mg/dl (265.2 μmol/l) or creatinine clearance \< 30 ml/min); * patients with previously diagnosed hemorrhagic tendency (including but not limited to): with hereditary hemorrhagic disorders, such as hemophilia, when screening; * patients with refractory hypertension that is difficult to be controlled by medication (systolic blood pressure \> 180 mmhg or diastolic blood pressure \> 110 mmhg); * patients with history of major head trauma or stroke within 1 month prior to randomization; * patients who have received intracranial or spinal surgery within 3 months prior to randomization; * patients with history of major surgery or serious physical trauma within 1 month prior to randomization; * patients with previously diagnosed hemorrhagic retinopathy; * male subjects (or their mates) or female subjects who had planned to have a child during the whole study period and within 3 months after the end of the study period or were unwilling to use one or more non-drug contraceptive methods (e.g., complete abstinence, condoms, ligation, etc.) during the study period; * patients with contraindications to known contrast agents or other contrast agents; patients who are allergic to cilostazol or dexborneol; * patients who plan to receive other surgical or intervention therapy within 3 months, which might require discontinuation of the study drugs; * patients with life expectancy of less than 3 months due to advanced stage of comorbidity; * patients who have received treatment of investigational drugs or devices within previous 3 months; * other investigator-evaluated conditions which may influence the compliance of patients or where it is not suitable for patients to participate in this trial.

Keywords: y-6 cilostazol dexborneol acute ischemic stroke large vessel occlusion reperfusion therapy future